Putting Together A Program Tuned To Patient, Staff
(Part 2 of a 2-part series)
by Dr. Sheila Dunn
Reprinted with Permission from Washington G-2 Reports,
Physician Office Testing, March 1999
If you manage a physician
office laboratory, you're perfectly suited to administer a patient self-testing
program. In Part I of this article, we
looked at the boom in the home testing market, with consumers keen on exercising
a more active role in managing their own health, aided by test kits and
instruments that are relatively simple to master and produce reliable results
when used correctly. Here, we'll examine how a patient self-testing program
can put your in-office lab at the forefront of this movement.
Taking The Plunge
Start with the idea of customizing the program to fit your physician practice:
the diverse categories of patients seen and your clinical, outreach, and
coordination capabilities. What works for one practice may not work for
another. Design the education and training you plan to offer to match test
complexity, system types, intended use (self-testing vs. self-management),
and professional disciplines.
Apart from training patients to use the testing devices,
your program must account for several other variables that can affect test
- Pre-analytical: specimens are collected properly; patient
performs the test at the right time; patient has taken proper preparations
- Post-analytical: clerical errors such as transposing
numbers, recording results wrongly or in the wrong place; sending the results
to the wrong caregiver; results not appropriately acted on; wrong patient
data used to calculate reference ranges (age, gender); self-monitoring
of diet and other lifestyle changes; noticing and reporting signs of adverse
outcomes (for example, bleeding indicators for prothrombin time testing).
Prior to developing your
program (Figure 1), ask the following questions:
- Justification: Why is the
program needed? What are the advantages/disadvantages of offering it? What
are the clinical applications?
- Logistics: Which groups of
patients will be targeted and accepted? Who in the office will coordinate
the program (documentation, instrument maintenance, training)? Where and
how will results be recorded?
- Technical issues: Which quality
control/quality assurance measures are needed (internal/external controls,
ongoing proficiency checks)? At what frequency should patients test? When
and how should test results be transmitted to caregivers? For patients
who will manage their disease at home, at what point(s) should the physician
The next step is to assess your costs, both direct and
indirect. Factor in projected savings associated with the program, such
as improved timeliness of patient assessment and intervention. Compare
the program's total cost with that you now incur with existing test methods.
Direct costs for home-based testing are: instruments,
reagents, supplies, waste from repeat testing (assume 5% repeat rate),
personnel, training, and program coordination. Indirect costs include medical
interventions, computer resources, telephones or pagers.
Consider which reimbursement resources can help support
your program. Medicare, for example, covers certified diabetes self-management
training (in both group and individual sessions) as well as related monitoring
devices and supplies under certain conditions (Physician Office Testing,
June, July '98, pp. 2-3). At this time, Medicare does not, however,
cover other forms of patient self-testing education/training, such as prothrombin
Managed care plans advocate programs that help enrollees
stay healthy, manage disease conditions at home, and avoid costly hospitalization
or other institutional care. Check your managed care contracts to determine
whether they reimburse such patient education/training. Your program could
be an excellent "selling point" to health plans which emphasize
outcomes-oriented care and heightened involvement of patients in activities
to maintain their own health.
Criteria to consider when
evaluating instruments for your program are summarized in Figure
2. Here are some added considerations.
- Manufacturer support: Obtain
references about the instrument's reliability and quality of support. Find
out where the nearest distributor is located and the approximate lead-time
once orders are placed. Investigate the possibility of obtaining a year's
worth of a single lot number of reagents. Be sure the manufacturer or distributor
has a toll-free 24-hour, 7 days a week technical support department. Will
the manufacturer supply a replacement instrument while repairs are performed?
Offer training for medical facility staff? Provide easy-to-read, quality
educational materials for patients? The manufacturer should provide an
instruction/operator's manual and cue cards outlining critical steps. Finally,
the instrument's specifications and limitations should be clearly indicated.
- Instrument characteristics: The
testing procedure should be acceptable to both the patient and the in-office
lab. Speed, ease, simplicity, and user-friendly operation are essential.
Assess the functional turnaround time capability, including patient preparation,
sample collection, test performance, and result documentation.
Low sample volume requirements are less invasive and less painful for the
patient. This is also important for patients who require frequent blood
glucose sampling and may have poor peripheral circulation.
Calibration and maintenance should be fast and simple. Regents and supplies
should be easy to store, preferably not require refrigeration, and have
a long shelf life. Error messages should be easy to interpret by operators.
Assess the size of the print on the display screen, because small print
may be hard for some operators to read. The size of the instrument, amount
of test supplies, and storage should afford easy handling and access for
The instrument must be rugged enough to survive home use, including all
kinds of conditions and accidents, as well as travel. It should include
a "low battery" indicator that can be tested routinely. Possible
sources of error should be minimal and be identified on cue cards.
Determine the method for documenting test results. Is the instrument capable
of interfacing with the laboratory/patient care information system?
- Instrument reliability: Assess
accuracy and strive for results within 10% of laboratory values, or define
acceptable limitations for imprecision at each specific medical decision
limit. A number of interferences, such as lipemia, hemolysis, hyperbilirubinemia,
and abnormal hematocrit, must be evaluated.
Operating The Program
For your program to be successful, comprehensive patient training is essential.
Your aim is to educate and motivate. According to the American Diabetes
Association (ADA), well-trained patients who perform their own glucose
tests at home are much more likely to avoid or delay the serious consequences
of diabetes. Better outcomes have also been reported for those who self-test
and self-manage anticoagulation therapy.
ADA provides guidelines for a comprehensive training program
for diabetes self-management. The program contains 20 standards which any
self-testing program should strive to achieve. For more information, contact
ADA's Education Recognition Department at 1-888-232-0822.
Training of both patients and program staff should address
the following issues:
- Patient preparation
- Sample handling
- Test performance
- Preventive maintenance, troubleshooting, and calibration
- Reagent storage and stability
- Knowledge of pertinent pre-analytic and post-analytic
- Test result evaluation, including proper follow-up procedures
- Quality control and evaluation of results
- Reporting results, along with steps to take if results
indicate further action
- Therapy adjustment
In addition to initial training, both patients and program
staff require periodic competence evaluations. Any one (or a combination
of) the following may be used:
- Blind samples
- Testing a sample in the presence of another trained observer
- Checklists to ensure conformance with the proper procedures
You'll find your program is not only a boon to current
patients, but also will attract others who value close, ongoing collaboration
with healthcare professionals in staying as healthy as they can be, for
as long as possible.
Figure 1: Steps In Devising Patient
(Return to text.)
- Analyze need
- Analyze cost/reimbursement
- Make "Go" or "No Go" decision
- Select instruments
- Design, implement education/training of patients, staff
- Establish results reporting system; if patient is to
self-manage, establish when interaction with caregiver is required
Source: Dunn, S. "Home-Based Testing." In
Point Of Care Testing: Principles, Management, and Clinical Practice, in
press. Ed: Gerald J. Kost, MD, PhD. New York: McGraw-Hill.
Figure 2: What To Look For When
Selecting Instruments For Your Patient Self-Testing Program
(Return to text.)
- Device warranty and repair policies
- Training for staff/patients (interactive, video, CD-ROM,
- Instructions for meeting CLIA/JCAHO requirements
- Therapeutic turnaround time
- Number & efficiency of pre-analytical, analytical,
- Flexibility, modularity, expandability, upgrade capability
- Networking or interfacing capability
- Information system, data storage, archiving capability
- Small sample volume
- Automated calibration
- Interrupt capability
- Short analysis cycle
- Compact, reliable, durable, lightweight, mobile, power-efficient
with battery operation
- Reagent stability, shelf life, lot size
- Accuracy, precision, bias, resolution, reproducibility,
stability, response time
- Linearity in both high and low extremes of measurement
- Consistency and relationship to tests performed in the
- Artifact elimination, error detection, interference warning,
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